For-D3 5000 Chewable Tablet

Vitamin D3 5000 IU

Category:

COMPOSITION :

FOR-D3® 5000 Chewable Tablet, each chewable tablet contains : Cholecalciferol 5000 IU equivalent to Vitamin D3 125 mcg.

 

INDICATION :

To increase the serum level of 25(OH)D in the blood in patients with Vitamin D deficiency (serum 25(OH)D < 30 ng/ml).

 

DOSAGE AND ADMINISTRATIONS : 

Adult and children above 12 years : 1 chewable tablet once a day.

Dosage should be adjusted based on the serum levels of 25-hydroxycholecalciferol (25(OH)D) and should not exceed 5000 IU/day.

 

CONTRAINDICATIONS :

  • Patients with hypersensitivity to Vitamin D and its analogues or to other components in the formula.
  • Hypercalcemia and/or hypercalciuria.
  • Calcium nephrolithiasis, nephrocalcinosis, hypervitaminosis D.
  • Severe kidney damage and kidney failure.

OVERDOSAGE :

Symptoms of hypercalcemia :

  • Anorexia, thirst, nausea and vomiting, constipation, abdominal pain, muscle weakness, fatigue, confusion, polydipsia, polyuria, bone pain, kidney calcification, kidney stones, vertigo and cardiac arrhythmias in severe cases.
  • Hypercalcemia in severe cases can lead to coma or death. Long-term high calcium levels can cause kidney damage and soft tissue calcification.
  • Overdose can cause hypervitaminosis, hypercalcemia and hyperphosphatemia.

Treatment of hypercalcemia :

  • Normalization of hypercalcemia due to Vitamin D poisoning lasts several weeks. Recommendations for the treatment of hypercalcemia are to avoid further administration of Vitamin D, including supplements, dietary intake and avoidance of sunlight.
  • A low-calcium or calcium-free diet may also be considered.
  • Rehydration and treatment with a diuretic such as furosemide to ensure adequate diuresis should be considered. Additional treatment with calcitonin or corticosteroids may also be considered.
  • Phosphate infusion should not be given to reduce hypercalcemia of hypervitaminosis D because it can pose a risk of dangerous metastatic calcification.

 

DRUG INTERACTIONS :

  • Phosphate infusion should not be given to reduce hypercalcemia of hypervitaminosis D because of the danger of metastatic calcification.
  • Patients treated with cardiac glycosides may be susceptible to high calcium levels and should have ECG parameters and calcium levels monitored. It is recommended to reduce the dose or stop treatment if the calcium content in the urine exceeds 7.5 mmol/24 hours (300 mg/24 hours).
  • Concomitant administration of Benzothiadiazine derivatives (thiazide diuretics) increases the risk of hypercalcemia because it reduces urinary calcium excretion. Plasma and urine calcium levels should be monitored for patients on long-term treatment.
  • If Cholecalciferol is combined with Vitamin D metabolites or analogues it is advisable to monitor serum calcium levels closely.
  • Anticonvulsants such as Phenytoin, Phenobarbital, Primidone can reduce the effect of Cholecalciferol due to the induction of liver enzymes.
  • Rifampicin can reduce the effectiveness of Cholecalciferol due to the induction of liver enzymes.
  • Isoniazid can reduce the effectiveness of Cholecalciferol because it inhibits the metabolic activation of Cholecalciferol.
  • Drugs that cause fat malabsorption, such as Orlistat, liquid paraffin, Cholestyramine, may interfere with the absorption of Cholecalciferol.
  • Cytotoxic drugs, actinomycin and antifungal drugs Imidazole interfere with vitamin D activation by inhibiting the conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin D-1-hydrosylase.
  • Concurrent use of glucocorticoids can reduce the effect of Vitamin D.
  • Avoid concomitant use with multivitamins and minerals (Vitamins A, D, E, K, folic acid and iron), calcitonin, etidronate, gallium nitrate, pamidronate or plicamycin.
  • Vitamin D may cause increased levels/effects of: Aluminum hydroxide, cardiac glycosides, magnesium salts, Sucralfate, Vitamin D analogues.
  • The level/effect of Vitamin D may be increased when used concomitantly with : Calcium salts, Conivaptan.
  • Vitamin D may decrease levels/effect of : Aripiprazole, Axitinib, Saxagliptin.
  • Levels/effects of Vitamin D may be decreased when used together with: Bile acid sequestrants, corticosteroids (systemic), inducers.
  • CYP3A4, Deferasirox, mineral oil, Orlistat, Sevelamer, Tocilizumab, anticonvulsants, hydantoins, barbiturates or Primidone.

 

WARNINGS AND PRECAUTIONS :

  • Cholecalciferol should be used with caution in patients with impaired renal function and monitoring of serum calcium and phosphate levels is necessary. The risk of soft tissue calcification must be taken into account. In patients with severe renal insufficiency, vitamin D in the form of cholecalciferol is not normally metabolized and other forms of vitamin D should be used.
  • Cholecalciferol should not be taken by patients with a tendency to form calcium-containing kidney stones.
  • Caution is required in patients receiving treatment for cardiovascular disease, such as cardiac glycosides.
  • There is a risk of hypocalcemia in patients with digitalis toxicity.
  • High doses of cholecalciferol should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increased metabolism of Vitamin D to its active form. These patients should be monitored for calcium content in serum and urine.
  • The need for additional calcium supplementation should be considered for each patient. Calcium supplements should be given under close medical supervision.
  • Medical supervision is required during treatment to prevent hypercalcemia.
  • The use of vitamin D preparations in the treatment of hyperparathyroidism associated with cardiovascular disease is not recommended because it can cause kidney failure.
  • Pregnancy : Cholecalciferol 5000 IU should not be used during pregnancy unless the woman’s clinical condition requires treatment with Cholecalciferol, at the dose required to overcome the deficiency.

During pregnancy women should follow the advice of the clinician as their needs may vary depending on the severity of their disease and their response to treatment.

Based on experience in humans and animal studies, overdose of Vitamin D can cause physical and mental disabilities, and congenital heart and eye conditions, due to hypercalcemia caused by administration of Cholecalciferol during pregnancy.

  • Breastfeeding : Cholecalciferol and its metabolites are excreted in breast milk. Overdose in infants caused by nursing mothers has not been observed. However, when prescribing supplemental Vitamin D to a breastfed child, the practitioner should consider any additional dose of Vitamin D given to the mother.
  • Effects on ability to drive and use machinery :No studies on the effects on ability to drive or use machinery have been conducted. Cholecalciferol has no known side effects that may affect the ability to drive and use or operate machinery.

 

ADVERSE REACTIONS :

  • Stop the use in case of a severe allergic symptoms, such as: face, lips, tongue and throat swelling, difficulty swallowing, hives and difficulty breathing.
  • Unusual side effects: Hypercalciuria and hypercalcemia.
  • Rare side effects: Pruritus, rash, urticaria.

 

PRESENTATIONS :

FOR-D3® 5000 available in the form of chewable tablets, brown color, chocolate smell, sweet chocolate taste, with the marking b breakline f on one side and plain on the other, packaged in :

Box, 3 strips @ 10 chewable tablets                                     Reg. No. : DKL2202366363A1

 

STORAGE :

STORE BELOW 30ºC, PROTECT FROM LIGHT

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by :

BERNOFARM

Sidoarjo – Indonesia

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